Methocarbamol

Product NDC: 67046-1147
Requested package NDC: 67046-1147-3
11-digit product format: 670461147
Labeler code: 67046
Product ID: 67046-1147_2cee3817-e6df-9db6-e063-6294a90a6ea1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA090200
Marketing category: ANDA
Marketing start: 2025-01-30
Substance: METHOCARBAMOL
Active strength: 750 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090200-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2009-11-06
A090200-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2009-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090200-001	AA
A090200-002	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090200-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090200-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090200-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090200-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090200-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090200-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090200-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090200-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090200-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090200-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090200-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090200-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090200-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090200-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090200-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090200-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090200-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090200-002	AA	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methocarbamol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHOCARBAMOL	750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
125OD7737X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197944	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2cee3893-70b7-6c2c-e063-6394a90aa79a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
492965be-47bc-38cf-57c4-5c5e0343abe5	Product name	6	20211028
02a01e9c-3f4e-c0ee-6542-be865127aea3	Product name	8	20190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-1147-3	Methocarbamol	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1147	METHOCARBAMOL TABLET [COUPLER LLC]	1	Current NDC, 1 package rows	20250131_2cee3893-70b7-6c2c-e063-6394a90aa79a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	American Health Packaging	d842fe4e-fc46-4d70-9ca3-b47191672f96	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Unit Dose Solutions, Inc.	5539d4f6-1192-2770-e063-6394a90a1e50	2026-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	31508051-c9cb-149b-e054-00144ff88e88	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	AvPAK	be37bc85-6a41-00d8-e053-2a95a90ae504	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Northwind Health Company, LLC	f31ccb09-7a9a-60af-e053-2995a90a6e97	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Northwind Health Company, LLC	df63611f-90e4-6bbe-e053-2a95a90a2aad	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	18810520-3040-4802-e063-6294a90a1ec0	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Cardinal Health 107, LLC	05b287d3-5004-4d8b-9ebe-a96caa2b8d89	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	9aed8304-fa4e-49d6-bd81-fcb3e4cc6173	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	ff55df39-e314-4120-8fab-3757cbe5a872	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	069045f1-d699-41d0-b674-cdb71cd5fbd0	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals Inc.	eed9ebd1-c243-4e82-bf4e-5fec370e722e	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Coupler LLC	2cee3893-70b7-6c2c-e063-6394a90aa79a	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200 ndc (package): 67046-1147-3 ndc (product): 67046-1147 ndc11 (package): 67046114703
Methocarbamol	METHOCARBAMOL	Advanced Rx Pharmacy of Tennessee, LLC	f4e98f9f-b20b-8608-e053-2a95a90aa6b0	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	3f47c39b-9373-454f-9a4e-ba6dd65dd7a4	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	add9e47f-11ac-e10d-bfc2-b9c52aa08fa5	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	NuCare Pharmaceuticals,Inc.	9d6024b2-ee1a-3a79-e053-2a95a90a1bf4	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	NuCare Pharmaceuticals, Inc.	3e89a426-c741-2f44-e054-00144ff8d46c	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	1880efb2-b97e-1e4d-e063-6294a90ab3e3	2024-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	XLCare Pharmaceuticals Inc.	f8bfb5cb-b7d0-4e09-b6bd-97a51d82c991	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
125OD7737X	METHOCARBAMOL	532-03-6	METHOCARBAMOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197944	methocarbamol 750 MG Oral Tablet	PSN	2cee3893-70b7-6c2c-e063-6394a90aa79a	1
197944	methocarbamol 750 MG Oral Tablet	SCD	2cee3893-70b7-6c2c-e063-6394a90aa79a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1147-3	67046114703	30 TABLET in 1 BLISTER PACK (67046-1147-3)	30 tablet	2025-01-30	No	No	Current